Gilead said the FDA accepted its supplemental New Drug Application for Yeztugo (lenacapavir) 300-mg tablets as a potential once-weekly oral PrEP option for HIV prevention. The FDA set a Prescription Drug User Fee Act (PDUFA) action date of February 2, 2027. The filing targets an inflection point for HIV prevention: shifting from injection schedules and adherence challenges toward an oral, long-acting-like dosing cadence. If approved, it would represent a significant expansion of options in the PrEP market. The acceptance does not guarantee approval, but it moves the program into a formal FDA review window with a defined timeline.